BD INSYTE AUTOG BC WING
Report
- Report Number
- 1710034-2024-01319
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 24, 2024
- Report Date
- January 2, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826339
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
ADDITIONAL INFORMATION: CUSTOMER CONFIRMS THE MATERIAL NUMBER AND LOT NUMBER REPORTEDLY AFFECTED AND CONFIRMED THAT THE OTHER LOT NUMBER PREVIOUSLY REPORTED IS NOT AFFECTED. THE MATERIAL INFORMATION UPDATED IN D. CUSTOMER RESPONSE ON (B)(6) 2024. THE LOT NUMBER THAT WE FOUND AN ISSUE WITH (NEEDLE RETRACTION SLOW AND FOREIGN MATTER) IS LOT NUMBER 4222721. TO VALIDATE THE SAFETY CONCERN, WE TESTED LOT NUMBER 4222721 WITH LOT NUMBER 4109663. WE DID NOT OBSERVE ANY ISSUES WITH LOT NUMBER 4019663.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 593 SEALED 20G X 1.0 INCH INSYTE AUTOGUARD BC UNITS FROM LOT #4222721. ABOUT 15 UNITS WERE PROVIDED IN A SMALL BAG ALREADY RETRACTED WITH A NOTE INDICATING THEY WERE TESTED. ADDITIONALLY, ONE PHOTO WAS PROVIDED. THE PHOTO DISPLAYS ONE UNIT ALREADY RETRACTED. THE PHOTO ONLY DISPLAYS A SMALL PART OF THE BARREL, AND NO DISCOLORED BARRELS WERE DISCOVERED FROM THE PHYSICAL SAMPLES. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR TESTING. A FUNCTIONAL TEST REVEALED THAT THE RETRACTION TIME OF 12 NEEDLES EXCEEDED THE 1.5 SECOND SPECIFICATION. YOUR REPORTED ISSUE WAS CONFIRMED AS A SLOW RETRACTION. FOREIGN MATTER WAS NOT CONFIRMED. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO EXCESSIVE GEL IN THE SPACE BETWEEN THE FLASH CHAMBER AND THE GRIP. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING FOREIGN MATTER NOTED IN THE INTERNAL SPRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM THE TEAM HAS IDENTIFIED IS THAT WHEN PRESSING THE WHITE BUTTON TO RETRACT THE NEEDLE, THERE IS A SIGNIFICANT DELAY IN THE NEEDLE RETRACTING / SHIELDING INTO THE BARREL. WHEN THE BUTTON IS PRESSED, THE NEEDLE SLOWLY RETRACTS AND THEN ABOUT HALFWAY THROUGH THE NEEDLE QUICKLY RETRACTS BACK INTO THE BARREL. UPON FURTHER ASSESSMENT, THE IDENTIFIED LOT NUMBER 4222721 HAS WHAT APPEARS TO BE A GEL COATING ON THE INTERNAL SPRING IN THE BARREL AS WELL AS A SLIGHT DISCOLORATION / FOGGINESS (WHICH IS NOTICEABLY DIFFERENT THAN OTHER LOT NUMBERS). POTENTIAL FOR NEEDLESTICK INJURY: (B)(6) 2024. WHAT WAS THE IMPACT TO THE PATIENT? NO PATIENTS HAVE BEEN DIRECTLY IMPACTED BY THIS FINDING TO OUR KNOWLEDGE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THE INCREASED LIKELIHOOD OF A NEEDLESTICK HAS BEEN REPORTED BY TEAM MEMBERS. TEAM MEMBERS HAVE IDENTIFIED THAT THE SLOW RETRACTION HAS RESULTED IN SEVERAL "NEAR MISSES" MEANING THAT THE INCIDENT DID NOT CAUSE AN INJURY, BUT COULD HAVE, GIVEN THE CIRCUMSTANCES. WAS BOTH ISSUE "NEEDLE RETRACTION SLOW" AND "DISCOLORATION / FOGGINESS" OBSERVED IN LOT# 4222721? YES, THAT IS CORRECT.
CUSTOMER RESPONSE ON (B)(6) 2024. THE LOT NUMBER THAT WE FOUND AN ISSUE WITH (NEEDLE RETRACTION SLOW AND FOREIGN MATTER) IS LOT NUMBER 4222721. TO VALIDATE THE SAFETY CONCERN, WE TESTED LOT NUMBER 4222721 WITH LOT NUMBER 4109663. WE DID NOT OBSERVE ANY ISSUES WITH LOT NUMBER 4019663.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1059552 | BD INSYTE AUTOG BC WING | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4222721 | 00382903826339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |